Functional Performance and Acceptability Study of Synthetic Nitrile, and Latex Graphene, Compared to Standard Latex Male Condom

NACompletedINTERVENTIONAL
Enrollment

480

Participants

Timeline

Start Date

May 11, 2021

Primary Completion Date

February 18, 2022

Study Completion Date

February 18, 2022

Conditions
Functional Performance
Interventions
DEVICE

Synthetic nitrite Condom

The condoms is composed of a synthetic nitrile rubber latex and 170 mm in length and is 53mm wide. It has a teat ended shape and bead retention mechanism at the top. It is pre-lubricated with silicone oil. It has a shelf-life of 5 years and clear and colourless. It is manufactured by Karex Industries. It is currently experimental.

DEVICE

Latex and graphene Condom

The condom is composed of a natural rubber latex with graphene. It is 170 mm in length and is 53mm wide. It has a teat ended shape and bead retention mechanism at the top. It is pre-lubricated with silicone oil. It has a shelf-life of 5 years and is greyish in colour. It is manufactured by Karex Industries. It is currently experimental.

DEVICE

Standard latex condom

The condoms is composed of a natural rubber latex. It is 180 mm in length and is 53mm wide. It has a teat ended shape and bead retention mechanism at the top. It is pre-lubricated with silicone oil. It has a shelf-life of 5 years and is natural in colour. It is manufactured by Karex Industries. It has World Health Organisation (WHO)/UNFPA, India Drug Control Authority, Conformitè Europëenne (CE) Mark of the European Union, South African Bureau of Standards and US FDA approval

Trial Locations (1)

4001

MatCH Research Unit [Maternal, Adolescent and Child Health Research Unit], Durban

All Listed Sponsors
lead

Prof Mags Beksinska

OTHER